URO-1, Inc. Aims to Advance Targeted Biopsy Technology to Support Diagnostic Precision and Pathology Workflow

URO-1, Inc. is a life sciences company dedicated to advancing the tools and workflows used in soft tissue biopsy diagnostics. Through innovations in biopsy instrumentation and specimen handling, the company focuses on supporting clinicians and pathologists with technologies intended to enhance tissue sampling volume and quality, while improving efficiency within diagnostic workflows.

The company’s origins trace back to a deeply personal experience for President and CEO Ted Belleza. While experiencing a prostate biopsy himself, he encountered a process that felt surprisingly complex. “As I spoke with my urologist, it became even clearer that, while imaging and molecular diagnostics had moved forward, the basic tools used to collect and transfer tissue samples hadn’t changed much. That contrast stayed with me and pushed me to read the literature on the lack of diagnostic accuracy of prostate biopsy compared with breast biopsy, and after interviewing a few key opinion leaders, I decided to start a venture to improve the diagnostic accuracy of the procedure,” he shares.

Belleza had spent more than four decades building companies across different industries, but the biopsy experience opened his eyes to a space where operational challenges and diagnostic uncertainty met in a meaningful way. “After selling my previous company, I expected to step back and focus on my family, but the questions I had during my own biopsy stayed with me,” he says. Over time, that curiosity grew into a motivation to develop technologies that could strengthen targeted biopsy performance and support more reliable diagnostic interpretation.

URO-1 was established to pursue that objective, focusing on two key parts of the biopsy pathway: tissue acquisition and specimen handling. The platform brings together two complementary technologies: the SUREcore® biopsy instrument and the coreCARE® tissue transfer system. Each supports a different step in the process, offering a coordinated approach to tissue collection and specimen preparation.

The SUREcore® system includes several configurations, including a disposable 18-gauge needle for its reusable handpiece, and a disposable 18-gauge biopsy instrument. Its design aims to obtain bigger, better, tissue samples and maintain consistent alignment during tissue sampling. “In targeted biopsy procedures, especially those guided by MRI-ultrasound fusion, keeping the device aligned with the intended area can make a meaningful difference in the diagnosis and risk stratification of prostate cancer,” Belleza explains.

Studies involving an 18-gauge needle design have explored performance characteristics relevant to tissue sampling, offering indications of how the approach may support tissue quality. Comparative research has shown increases in tissue volume by weight, about 11% in transrectal ultrasound-guided procedures and 21% in transperineal biopsies, when compared with standard of care (SoC). Researchers have also evaluated factors such as fragmentation and tortuosity, which may influence histologic preparation and interpretation by pathology.

Meanwhile, the coreCARE® tissue transfer system focuses on specimen retrieval immediately after tissue collection. The system incorporates a method described as “touch and go,” which allows the biopsy core to be transferred from the needle with minimal manual manipulation. URO-1 notes that the design seeks to preserve tissue orientation and structural integrity while supporting efficient handling within the histology laboratory.

Together, the SUREcore® and coreCARE® technologies form a workflow that connects the procedural environment with downstream pathology analysis. Belleza emphasizes that the goal extends beyond instrument design alone. “Every biopsy is part of a diagnostic journey that moves from the procedural suite to the pathology laboratory,” he explains. “Our objective has been to examine that entire sequence and develop tools that support each step cohesively.”

Early institutional adoption has provided opportunities to evaluate the URO-1 platform in clinical environments. The company’s biopsy instruments and tissue transfer system have received value analysis committee (VAC) approval within the Novant Health hospital network. According to URO-1, the devices are currently in use at several hospitals across North Carolina and South Carolina, while an ongoing clinical study evaluates specimen characteristics and diagnostic parameters associated with the technology.

Pathology teams participating in these evaluations have examined specimen characteristics such as tissue area and integrity during histologic preparation. Interim analyses from a multicenter prospective study involving prostate biopsy procedures have reported larger tissue, reduced fragmentation, and tortuosity when the novel needle design and retrieval method are used together, compared with SoC.

Regulatory clearance supports application across all soft tissue biopsies. The SUREcore® and coreCARE® systems have received clearance from the U.S. Food and Drug Administration for use in soft tissue biopsies. Belleza says, “This clearance gives clinicians across areas like prostate, breast, liver, lung, kidney, and lymph node sampling, the opportunity to see how the technology may fit within their own diagnostic workflows.”

As clinical experience expands, URO-1 continues to strengthen institutional partnerships. URO-1 is a portfolio company of the North Carolina Biotechnology Center, a state-supported agency that aims to sustain and grow the life sciences industry within the state. Belleza notes that this affiliation has provided strategic support as the company progresses through product development, clinical studies, and market expansion.

Future development plans extend across several dimensions. URO-1 aims to increase adoption in hospital systems across North Carolina while expanding into major health systems throughout the United States, including Military hospitals and VA medical centers. Parallel efforts are underway to introduce the platform to international markets and to explore additional clinical applications, including interventional radiology and breast biopsy procedures.

Belleza views this trajectory as part of a larger vision focused on targeted biopsy innovation. “Our work is guided by a simple principle,” he remarks. “Every improvement in how tissue is collected and preserved has the potential to support clearer interpretation by the pathologist and more confident clinical decision-making.” With continued clinical studies, institutional partnerships, and technology development, URO-1 remains focused on advancing biopsy instrumentation and specimen handling systems that contribute to the evolving landscape of soft tissue diagnostics.